Velcade (bortezomib) phase III clinical trial initiated in patients with newly diagnosed multiple myeloma

Millennium Pharmaceuticals today announced, in collaboration with Johnson & Johnson Pharmaceutical Research & Development, LLC, the initiation of VISTA (Velcadeas Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone), a multicenter, international phase III clinical trial of Velcadein combination with melphalan and prednisone versus melphalan and prednisone in patients with newly diagnosed multiple myeloma (MM) who are not transplant candidates.

This large, international randomized study will assess efficacy, overall safety and tolerability of the combination versus melphalan and prednisone alone.

The VISTA trial was reviewed by the U.S. Food and Drug Administration (FDA) through the special protocol assessment (SPA) process. An SPA is a binding agreement between the FDA and the sponsor of a clinical trial requiring that the study design meets the scientific and regulatory requirements of the FDA to support a New Drug Application (NDA) or supplemental New Drug Application (sNDA).

Velcadeis currently approved in the United States and Europe for the treatment of patients with relapsed and refractory MM. The FDA is currently reviewing the Company's supplemental sNDA, under Priority Review designation, for Velcadeas a treatment for patients with MM who have received at least one prior therapy.

"Millennium, and our partner Johnson and Johnson, are committed to strategically and expeditiously developing Velcadeas the cornerstone of care across the multiple myeloma treatment paradigm," said David Schenkein, M.D., vice president, clinical oncology development, Millennium. "The frontline data seen to date have been very promising, and we are eager to explore the potential of Velcadein combination with other therapies so that we may be able to offer new options for patients in need."

Millennium and Johnson & Johnson are also planning to support two additional large, multi-national phase III frontline MM trials scheduled to be initiated in the first half of this year. These trials will be for patients who plan to undergo stem cell transplantation. In these trials, which are planned to be conducted by major European hematology cooperative groups, Velcadewill be integrated into the induction regimen.

Millennium supported the presentation of encouraging data at the 2004 46th Annual Meeting of the American Society of Hematology (ASH) meeting exploring the use of Velcadein treating newly diagnosed MM. Overall response rates from ongoing investigator-initiated studies evaluating Velcadein combination with other commonly used agents in untreated MM ranged from 95 percent to 73 percent with complete and near-complete response rates ranging from 25 to 17 percent. Adverse events were similar to those observed in other clinical trials with Velcadeand included gastrointestinal events, neuropathy, fatigue, and hematologic toxicities.

Millennium and Johnson & Johnson continue to investigate Velcadeglobally in both hematologic and solid tumors and are currently supporting more than 100 ongoing or planned clinical trials.

Multiple myeloma is a cancer of the bone marrow in which white blood cells called plasma cells, normally responsible for the production of antibodies (proteins that fight infection and disease), are overproduced. The proliferation of these abnormal plasma cells, known as myeloma cells, causes decreased production of normal red and white blood cells, and of normal disease-fighting antibodies, as well as the growth of tumors that spread to multiple sites -- hence the term multiple myeloma. The decreased white blood cell production damages the immune system while the myeloma tumors cause bone destruction that manifests as pain and fractures.

MM is the second most common hematologic malignancy and although the disease is predominantly a cancer of the elderly (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and younger age of onset. In the United States, more than 40,000 individuals have MM and over 14,000 new cases of the disease are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths due to multiple myeloma each year.

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